September Women's Health Update: FDA Office of Women's Health

For Women

Message from the Director

As we move into Fall, I encourage you to continue to look to FDA for resources to help you and the women you serve make smart choices about the use of FDA-regulated products. If you are planning outreach activities to commemorate health observances like healthy aging month or food safety month, FDA has digital and print resources that you can use. If you are looking for information on the latest recalls and safety alerts, we have that too. In this update, you will find a snapshot of the tools and tips that FDA has to offer.  So, check out these alerts and always look to www.fda.gov/womensfor more.

Marsha Henderson - Assistant Commissioner for Women’s Health

Public Meeting on Hormonal Contraceptives

On November 9, 2015, FDA will hold a public meeting entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”. The input received may be used to refine FDA’s thinking on HC drug interaction study design and interpretation and labeling communication on drug interaction risk.   You may attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Please register by October 9, 2015. View the Meeting and Registration Announcement

Injectable Skin Lightening Products

Some consumers seeking to change their skin color are turning to injectable products marketed to whiten or lighten their complexion. These products are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants. FDA has not approved any injectable drugs for skin whitening or lightening.  What You Should Know about Injectable Skin Lightening Products

New Healthy Aging Webpage

September is Healthy Aging Month. Healthy aging involves good habits like eating healthy, avoiding common medication mistakes, managing health conditions, getting recommended screenings, and being active. OWH has launched a new webpage to connect older women with FDA resources to support healthy lifestyle choices and safe medication practices. 5 Healthy Aging Tips for Women

Drug Safety Communication: DPP-4 Inhibitors for type 2 diabetes

FDA is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.

Read the Safety Announcement

Webinar on Participating in Clinical Trials

FDA’s Office of Minority Health and Rebecca Williams, Assistant Director of ClinicalTrials.gov, will conduct a webinar on September 29 at 11 AM EST to explain what information is available on ClinicalTrials.gov and show participants how to find trials.

Register for the Webinar

FDA Meetings

Obstetrics and Gynecology Devices Panel – Medical Devices Advisory Committee

September 24, 2015 - FDA White Oak Campus, Silver Spring, MD

Public Workshop: Medical Device Patient Labeling

September 29-30, 2015 - FDA White Oak Campus, Silver Spring, MD

Public Meeting: Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access

October 5, 2015 - FDA White Oak Campus, Silver Spring, MD